BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Truer Bougie

    DI: 00859290006236 · Model: 90552 · TRUER MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Truer Bougie
    Primary DI
    00859290006236
    Version / Model
    90552
    Company Name
    TRUER MEDICAL, INC.
    Labeler DUNS
    003530786
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-29
    Public Version
    1
    Public Version Date
    2022-09-06
    Public Version Status
    New
    Public Device Record Key
    5811532c-f88d-4f43-8210-5a2b1e4fd657

    Device Description

    Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCD Bougie, Esophageal, Ent

    GMDN Terms

    Code Name
    41829 Endotracheal tube introducer, single-use

    Identifiers

    Type ID
    Primary 00859290006236
    Package 10859290006233
    Package 30859290006237